Nested Study: Identifying Risk for Diabetes and Heart Disease in Women: A Study of African-American, African and White Federal Employees and Contractors

National Institute Of Diabetes And Digestive And Kidney Diseases

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Abstract

The Federal Women's Study: Nested Study of Hepatic Glucose Production The Federal Women's Study is an active clinical protocol recruiting 360 federal employees and contractors (120 African-American, 120 African immigrant, 120 white) working in the Washington DC metropolitan area and aims to identify the earliest risk factors for diabetes and heart disease by race and ethnicity. To help unravel the complex association of race, hepatic insulin resistance and the pathway to diabetes, this nested study was designed to evaluate one of the diabetes risk factors, hepatic glucose production. This project evaluates the components of hepatic glucose production (gluconeogenesis and glycogenolysis) and the contribution of hepatic to total body insulin resistance by race and ethnicity. Eligible women (30 African descent and 30 white) who participate in the primary protocol (13-DK-0090) are invited to participate in the nested study to measure glucose and fat metabolism and energy expenditure. Recruitment for the tracer study began in September 2014. Thirty-two women have been screened and 16 women (7 African-American, 1 African immigrant, 8 white) were enrolled. The most common reason that screened women were not enrolled in the nested study was undiagnosed anemia (31%) detected at screening evaluation. In addition, recruitment for the tracer study was temporarily suspended in June 2015 because of processing difficulties with the NIH Pharmacy Development Service. We anticipate resuming recruitment within the next month. Interim analyses will be conducted after 15 African descent and 15 white women have completed the protocol. In summary, we are undertaking a mechanistic approach to understanding the biology of health disparities in diabetes. In the effort to curb the epidemic of cardiometabolic disease worldwide, these findings will help to determine the utility of fasting hyperglycemia as an effective screening test for diabetes in the African diaspora.